BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD ANT STBLZD BRG 12X67

    MDR report key: 4616877 · Received March 19, 2015

    Report

    Report Number
    0001825034-2015-01040
    Event Type
    Injury
    Date Received
    March 19, 2015
    Date of Event
    February 20, 2015
    Report Date
    February 24, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK050222
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOTS RELEASED WITH NO RECORDED ANOMALIES RELATED TO THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 189042, LOT NUMBER - 251720, EXPIRATION DATE ¿ DEC 31, 2017, MANUFACTURE DATE ¿ DEC 30, 2012. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 189040, LOT NUMBER - 010420, EXPIRATION DATE - MAY 31, 2019, MANUFACTURE DATE ¿ MAY 19, 2014. REVIEW OF STERILIZATION CERTIFICATIONS CONFIRMS BOTH ABOVE DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015- 01037 / 01040).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON THE LEFT SIDE ON (B)(6) 2015 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED DURING THE REVISION SURGERY AND THE PATIENT WAS RE-IMPLANTED WITH COMPETITOR PRODUCTS EXCEPT FOR A BIOMET FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188287 VNGD ANT STBLZD BRG 12X67 PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 251720

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R